Steering mechanism

ABSTRACT

A hand-holdable steering mechanism is used as part of a medical device such as a catheter or an endoscope to allow movement of a steerable distal portion of the catheter or endoscope. The mechanism can include a housing, a first actuator, and a second actuator. The first actuator is configured to move the steerable portion along a first plane when the first actuator is moved between first and second positions. The second actuator is configured to move the steerable portion along a second plane different than the first plane when the second actuator is moved between first and second positions.

CROSS-REFERENCE TO RELATED CASE

This application is a Continuation Application of U.S. patentapplication Ser. No. 14/054,452, filed Oct. 15, 2013, which is aContinuation Application of U.S. patent application Ser. No. 13/243,937,filed Sept. 23, 2011, now U.S. patent Ser. No. 8,585,639, which is aContinuation Application of U.S. patent application Ser. No. 12/389,697,filed Feb. 20, 2009, now U.S. Pat. No. 8,048,024, which claims priorityto, and the benefit of Provisional U.S. patent application Ser. No.61/037,131, filed Mar. 17, 2008, all of which are incorporated herein byreference in their entirety.

TECHNICAL FIELD

The invention generally relates to a mechanism for controllingarticulation of a steerable portion of a medical device, and moreparticularly to a one-handed or one-fingered steering mechanism. Themechanism can control articulation of the steerable portion on at leasttwo planes so that 360 degree articulation of the steerable portion isachievable.

BACKGROUND INFORMATION

Steering mechanisms are used to steer or direct a medical instrument,for example a catheter or endoscope, to a desired position or locationin a body of a patient. One known steering mechanism resembles ajoystick. The configuration of the joystick usually includes a plateattached to control wires. The plate, however, must be large toaccommodate the desired articulations of the steerable medical device.Additionally, the single control element encompassed in the joystickcontrol mechanism makes the introduction of force leverage difficult,especially in a procedure during which an increased leverage is neededfor different articulation planes. Further, all control wires aremanipulated by the joystick, and therefore movement of the joystick maycause additional, albeit unintended, articulation of the catheter orendoscope.

Another known steering mechanism includes multiple slidable buttons.Each button is connected to a puller wire so that when the button ismoved, the puller wire moves the catheter in a single directionassociated with the puller wire. Thus, at least four slidable buttonsare required to achieve 360 degree articulation of the catheter orendoscope. The sliding motion of the buttons on this steering mechanismmakes introduction of force leverage very difficult. Furthermore, thecatheter can only be articulated along one plane at a time unless theuser moves more than one button at the same time, which requires thatthe user either use multiple fingers or continuously move his or herhand to manipulate the buttons and operate the device.

SUMMARY OF THE INVENTION

It is an object of the invention to allow steering operation by a singlehand or a single finger of a user. A steering mechanism according to theinvention can control 360 degree articulation of a steerable portion ofa medical device. A steering mechanism of the invention also canintroduce force leverage for articulating a steerable device. A steeringmechanism of the invention also can articulate a steerable device alongone plane without unintentionally articulating the steerable devicealong a different plane.

In one aspect, the invention relates to a steering mechanism for use aspart of a medical device. The steering mechanism can comprise a housing,a first actuator and a second actuator. The housing can include aproximal end portion and a distal end portion. The housing extends alonga longitudinal axis and is configured to be coupled to a deviceincluding a steerable member. The first actuator is movably coupled tothe housing and is adapted to move between a first position and a secondposition different than the first position. The first actuator can bemovable with respect to a first axis that is different than thelongitudinal axis defined by the housing. The first actuator can beadapted to move the steerable member of the device along a first planewhen the housing is coupled to the device and when the first actuator ismoved between its first position and its second position. The secondactuator can be coupled to the housing and can be movable between afirst position and a second position with respect to a second axisdifferent than the first axis. The second actuator can be adapted tomove the steerable member of the device along a second plane differentthan the first plane when the housing is coupled to the device and whenthe second actuator is moved between its first position and its secondposition.

Embodiments according to this aspect of the invention can includevarious features. For example, the first actuator can be movable withrespect to an axis that is orthogonal to the longitudinal axis definedby the housing. The first actuator and the second actuator can bedisposed on the proximal end portion of the housing. In another example,the first actuator can be adapted to move the steerable member of thedevice along a substantially vertical plane and the second actuator canbe adapted to move the steerable member of the device along asubstantially horizontal plane. At least one of the first and secondactuators is independently movable of the other of the first and secondactuators.

The first and second actuators can be adapted for at least one ofone-handed or one-fingered operation by a user. At least one of thefirst and second actuators is adapted to introduce force leverage to aportion of the steering mechanism when the at least one of the firstactuator and the second actuator is moved by a user. The second actuatorcan be adapted to directly transfer motion to a wire coupled to thesteerable member of the device. The second actuator can be movablycoupled to the first actuator.

In another example, the housing of the steering mechanism can furthercomprise a cam disposed in the housing. The cam can be coupled to thefirst actuator and movable between a first position and a secondposition different then the first position. The steering mechanism canalso comprise a wire that includes first and second ends. At least aportion of the wire can engage the cam and at least a portion of thewire can be couplable to the steerable member of the device.

In another aspect, the invention generally involves a medical devicethat includes an elongated member and a steering mechanism. Theelongated member includes a proximal end and a distal end and defines alumen at least partially therethrough. The elongated member cansubstantially extend along a longitudinal axis. The elongated member caninclude a steerable portion, and at least a portion of the steerableportion can be movable along a first plane and a second plane differentthan the first plane such that the steerable portion is movable insubstantially any direction 360 degrees around the longitudinal axis.The steering mechanism is couplable to the elongated member and isadapted for one-fingered operation by a user. The steering mechanism isconfigured to move the steerable portion of the elongated member alongthe first plane and along the second plane different than the firstplane. The steering mechanism comprises a first actuator and a secondactuator. The first actuator is movable with respect to a first axisdifferent than the longitudinal axis, and is adapted to move thesteerable portion of the elongated member along the first plane. Thesecond actuator is adapted to move the steerable portion of theelongated member along the second plane, and is selectively actuatablesubstantially simultaneously with the first actuator.

Embodiments according to this other aspect of the invention can includevarious features. For example, the second actuator can be movablycoupled to the first actuator. The steering mechanism can include ahousing that defines a proximal end portion and a distal end portion,and the elongated member can be couplable to the distal end portion ofthe housing.

In another example, the medical device further comprises a verticalplane wire and a horizontal plane wire. At least a portion of thevertical plane wire can be coupled to the first actuator, and at least aportion of the vertical plane wire can be coupled to the steerableportion of the elongated member. At least a portion of the horizontalplane wire can be coupled to the second actuator, and at least a portionof the horizontal plane wire can be coupled to the steerable portion ofthe elongated member. The housing of the steering mechanism can definean interior cavity, and the vertical and horizontal plane wires can eachextend from the steerable portion of the elongated member through atleast a portion of the interior cavity of the housing.

In another example, the steering mechanism can further comprise ahousing that defines an interior cavity and a cam disposed in theinterior cavity. The cam can be coupled to the first actuator andconfigured to move between a first position and a second positiondifferent than the first position in response to movement of the firstactuator. The medical device can further include first and secondvertical plane wires. The first and second vertical plane wires can becoupled to the steerable portion of the elongated member. At least aportion of each of the first and second vertical plane wires can becoupled to the cam. The first and second vertical plane wires can bemovable in response to movement of the first actuator. The firstvertical plane wire can be adapted to move the steerable portion of theelongated member in a first direction along the first plane, and thesecond vertical plane wire can be adapted to move the steerable portionin a second direction along the first plane different than the firstdirection along the first plane.

In a further example, the medical device can include first and secondhorizontal plane wires. The first and second horizontal plane wires canbe coupled to the steerable portion of the elongated member, and atleast a portion of each of the first and second horizontal plane wirescan be coupled to the second actuator. The first and second horizontalplane wires can each be movable in response to movement of the secondactuator. The first and second horizontal plane wires can be adapted tomove the steerable portion of the elongated member in a first directionand a second direction different than the first direction, respectively,along the second plane.

BRIEF DESCRIPTION OF THE DRAWINGS

For a fuller understanding of the nature and operation of variousembodiments according to the present invention, reference is made to thefollowing description taken in conjunction with the accompanying drawingfigures which are not necessarily to scale and wherein like referencecharacters denote corresponding or related parts throughout the severalviews.

FIG. 1 is a schematic illustration of a steering mechanism for use withor as part of a medical device according to an embodiment of theinvention.

FIG. 2 is a schematic illustration of a medical device according to anembodiment of the invention.

FIG. 3 is a side view of a medical device according to an embodiment ofthe invention.

FIG. 4 is an end view of a portion of the medical device of FIG. 3.

FIG. 5 is a perspective view of a portion of the medical device of FIG.3 with a portion of a housing removed.

FIGS. 6A-6C are side views of the medical device of FIG. 3 in operationby a user with a first actuator in a first position, second position,and third position, respectively.

FIGS. 7A-7C are top views of the medical device of FIG. 3 with a secondactuator in a first position, second position, and third position,respectively.

FIGS. 8A and 8B are perspective views of the medical device of FIG. 3with a user's hand in a first position and a second position,respectively.

FIG. 9 is a perspective view of a portion of a steering mechanism of amedical device according to an embodiment of the invention.

DESCRIPTION

Apparatuses for controlled articulation of a steerable device aredescribed herein. For example, in some embodiments, the apparatus is asteering mechanism for use as part of a medical device. The steeringmechanism can be used as part of or with a medical device including asteerable member, such as, for example, a catheter or endoscope.

In one embodiment, as schematically illustrated in FIG. 1, the apparatus1100 is a steering mechanism. The steering mechanism 1100 includes ahousing 1200, a first actuator 1400, and a second actuator 1500. Thehousing 1200 is configured to be coupled to a device including asteerable member (not illustrated in FIG. 1).

The first actuator 1400 is coupled to the housing 1200. In someembodiments, the first actuator 1400 is movably coupled to the housing1200. The first actuator 1400 is configured to move the steerable memberof the device. In some embodiments, when the housing 1200 is coupled tothe device, the first actuator 1400 is configured to move the steerablemember along a first plane when the actuator is actuated.

The second actuator 1500 is coupled to the housing 1200. In someembodiments, the second actuator 1500 is movably coupled to the housing1200. The second actuator 1500 is configured to move the steerablemember of the device. In some embodiments, when the housing is coupledto the device, the second actuator 1500 is configured to move thesteerable member along a second plane different than the first planewhen the second actuator is actuated.

In some embodiments, as schematically illustrated in FIG. 2, theapparatus 2000 is a medical device including an elongated (or steerable)member 2001 and a steering mechanism 2100. The steering mechanism 2100is configured to control movement (or articulation) of the elongatedmember 2001.

The elongated member 2001 includes a proximal end 2320 and a distal end2310 and defines a lumen (not illustrated) therethrough. The termsproximal and distal require a point of reference. In this application,the point of reference is the perspective of the user. Therefore, theterm proximal will always refer to an area closest to the user, whereasdistal will always refer to an area away from the user. At least aportion of the elongated member 2001 is configured to be steerable. Saidanother way, in some embodiments, the elongated member 2003 includes asteerable portion 2300. The steerable portion 2300 of the elongatedmember 2001 is movable along a first plane and a second plane differentthan the first plane. For example, in some embodiments, the steerableportion 2300 is movable on a vertical plane and a horizontal plane.

The steering mechanism 2100 is couplable to the elongated member 2001.For example, in some embodiments, the steering mechanism 2100 is coupledto the proximal end 2320 of the elongated member 2001.

In some embodiments, the steering mechanism 2100 is adapted for at leastone of one-handed or one-fingered operation by a user. Said another way,a user can manipulate or control articulation of the steerable portionof the elongated member by controlling the steering mechanism 2100 witha single hand or finger. The steering mechanism 2100 is configured tomove the steerable portion 2300 of the elongated member 2001 along thefirst plane and the second plane different than the first plane.

In some embodiments, the steering mechanism 2100 includes a firstactuator 2400 and a second actuator 2500. The first actuator 2400 isconfigured to move the steerable portion 2300 of the elongated member2001 along the first plane. The second actuator 2500 is configured tomove the steerable portion 2300 along the second plane.

As illustrated in FIG. 3, an apparatus 3000, or medical device (alsoreferred to herein as “device”), according to some embodiments of theinvention includes an elongated member 3001 and a steering mechanism3100. The medical device 3000 substantially extends along a longitudinalaxis L.

As illustrated in FIG. 3, the elongated member 3001 substantiallyextends along the longitudinal axis L when the elongated member is in anon-articulated (or relaxed) position (also referred to as the “firstposition”). In some embodiments, the elongated member 3001 is biasedtowards the straight or relaxed position. For example, in someembodiments, the elongated member is a catheter or endoscope of greaterlength (such as compared to the length of the steering mechanism) thanthe steerable member in the illustrated embodiment.

The elongated member 3001 includes a proximal end 3310 and a distal end3320 and defines a lumen 3350 at least partially therethrough. At leasta portion of the elongated member 3001 is a steerable portion 3300. Atleast a portion of the steerable portion 3300 is movable along at leasta first plane and a second plane different than the first plane. Thesteerable portion 3300 of the elongated member 3001 is movable insubstantially any direction 330 degrees around the longitudinal axis L.In some embodiments, the elongated member 3001 is a catheter orendoscope.

The steering mechanism 3100 is adapted to control articulation of atleast a portion of the elongated member 3001 (or steerable member) ofthe device 3000. In some embodiments, the steering mechanism 3100 isconfigured to move a steerable portion 3300 of the elongated member 3001along a first plane and along a second plane different than the firstplane.

As illustrated in FIGS. 3-6, in some embodiments, the steering mechanism3100 includes a housing 3200, a first actuator 3400, and a secondactuator 3500. The steering mechanism 3100 is adapted to be coupled tothe elongated member 3001. In some embodiments, the steering mechanism3100 is removably coupled to the elongated member 3001. In theillustrated embodiment, the housing 3200 of the steering mechanism 3100is couplable to the elongated member 3001. For example, in FIG. 3, adistal end portion 3220 of the housing 3200 is coupled to the elongatedmember 3001.

As illustrated in FIG. 4, the housing 3200 extends along thelongitudinal axis L. The housing 3200 includes a proximal end portion3210 and a distal end portion 3220. As illustrated in FIG. 6, thehousing 3200 defines an interior cavity 3240. In some embodiments, theinterior cavity 3240 extends from the proximal end 3210 to the distalend 3220 of the housing 3200.

A cam 3230 is disposed in the housing 3200. The cam 3230 is configuredto move the steerable member 3001 of the device 3000. In the illustratedembodiment, the cam 3230 is disposed in the interior cavity 3240 of thehousing 3200 towards the proximal end 3210 of the housing. In otherembodiments, the cam can be disposed in or on a different portion of thehousing.

The cam 3230 is coupled to the first actuator 3400. The cam 3230 ismovable between a first position and a second position different thanthe first position. As described in more detail below, the cam isconfigured to move in response to movement of the first actuator 3400.Although the steering mechanism 3100 is illustrated and described hereinas including a cam 3230 to move the steerable member, in otherembodiments, the steering mechanism includes no cam.

The first actuator 3400 of the steering mechanism 3100 is adapted tocontrol articulation of the steerable member 3001 of the device 3000along at least a first plane. The first actuator 3400 is configured tomove the steerable member of the device in at least a first directionand a second direction different than the first direction along thefirst plane, as illustrated in FIGS. 6A-6C.

The first actuator 3400 is adapted for at least one of one-handed orone-fingered operation by a user (as illustrated in FIGS. 6A-6C and8A-8B). For example, during an endoscopic procedure, a physician canhold the housing 3200 of the steering mechanism 3100 in his or her handwhile controlling movement of the first actuator 3400 with a thumb ofthe same hand, as shown in FIG. 8A. In another example, a physician canhold or rest the housing 3200 of the steering mechanism 3100 in his orher hand while controlling movement of the first actuator 3400 with afinger of the same hand, as shown in FIG. 8B.

The first actuator 3400 is movably coupled to the housing 3200. In theillustrated embodiments, the first actuator 3400 is disposed on theproximal end portion 3210 of the housing 3200.

The first actuator 3400 is configured to move between a first (orrelaxed) position (illustrated in FIG. 6A) and a second positiondifferent than the first position (illustrated in FIG. 6B). When thehousing 3200 of the steering mechanism 3100 is coupled to the steerablemember 3001 of the device 3000, the first actuator 3400 is configured tomove the steerable member along the first plane when the first actuatoris moved between its first position and its second position. In someembodiments, the first actuator 3400 is configured to move the steerablemember along a substantially vertical plane. In other embodiments, thefirst actuator is configured to move the steerable member along adifferent plane.

In some embodiments, the first actuator 3400 is configured to movebetween its first position and its second position about or with respectto a rotational axis R, illustrated in FIG. 4. The rotational axis R isdifferent than the longitudinal axis L along which the housing extends.In the illustrated embodiment, rotational axis R is orthogonal to thelongitudinal axis L defined by the housing.

As illustrated in FIG. 4, in some embodiments, the first actuator 3400includes a first attachment portion 3410, a second attachment portion3420, and an arm portion 3430 extending therebetween. At least one ofthe first attachment portion 3410 and the second attachment portion 3420is coupled to the housing 3200. The first actuator 3400 turns or pivotsat the attachment portions 3410, 3420 coupled to the housing when thefirst actuator is moved between its first position and its secondposition. In some embodiments, the arm portion 3430 of the firstactuator 3400 is moved, or flipped, about the proximal end 3210 of thehousing 3200 when the first actuator 3400 is moved between its firstposition and its second position. Because the first actuator 3400 pivotsat first axis R, for example as opposed to being moved linearly, thefirst actuator is adapted to introduce force leverage to move thesteerable member 3001 of the device 3000.

Although the first actuator 3400 is illustrated and described asincluding two attachment portions 3410, 3420, in other embodiments, thefirst actuator can include any number of attachment portions. Forexample, in one embodiment, the first actuator includes a singleattachment portion at which the first actuator is coupled to thehousing.

In the illustrated embodiment, the first attachment portion 3410 of thefirst actuator 3400 is coupled to the cam 3230 disposed within thehousing 3200. Movement of the first actuator 3400 between its firstposition and its second position directly transfers motion onto the cam3230. Said another way, when the first actuator 3400 is moved from itsfirst position to its second position, the cam 3230 moves from its firstposition to its second position,

In some embodiments, the steering mechanism 3100 includes a firstvertical plane wire 3610 and a second vertical plane wire 3630. Thevertical plane wires 3610, 3630 are adapted to move the steerable member3001 of the device 3000 along the first plane. The first vertical planewire 3610 is configured to move the steerable member in a firstdirection along the first plane. In some embodiments, for example, thefirst vertical plane wire 3610 is configured to move the steerablemember in a first vertical direction; for example, “up” from theperspective of the user. All relative descriptions herein such as top,bottom, left, right, up, and down are with reference to the figures, andthus should not be construed in a limiting sense.

The second vertical plane wire 3630 is configured to move the steerablemember 3001 of the device 3000 in a second direction different than thefirst direction along the first plane. In some embodiments, for example,the second vertical plane wire 3630 is configured to move the steerablemember 3001 in a second vertical direction different than the firstvertical direction; for example, “down” from the perspective of theuser.

In some embodiments, the first vertical plane wire 3610 is coupled tothe first actuator 3400. For example, the first vertical plane wire 3610includes a first end and a second end (not shown). In some embodiments,the first end of the first vertical plane wire 3610 is coupled to thefirst actuator 3400. In the illustrated embodiment, at least a portionof the first vertical plane wire 3610 is engaged with or coupled to thecam 3230, which is coupled to the first actuator 3400.

The first vertical plane wire 3610 is couplable to the steerable member3001 of the device 3000. For example, in the illustrated embodiment, thesecond end of the first vertical plane wire 3610 is couplable to thesteerable member 3001 of the device 3000.

In some embodiments, the second vertical plane wire 3630 is coupled tothe first actuator 3400. For example, the second vertical plane wire3630 includes a first end and a second end (not shown). In someembodiments, the first end of the second vertical plane wire 3630 iscoupled to the first actuator 3400. In the illustrated embodiment, atleast a portion of the second vertical plane wire 3630 is engaged withor coupled to the cam 3230, which is coupled to the first actuator 3400.

As illustrated in FIG. 5, in some embodiments, the cam 3230 defines atleast one groove 3232. The groove 3232 is configured to receive aportion of at least one of the vertical plane wires 3610, 3630. In theillustrated embodiment, the groove 3232 is receiving a portion of thesecond vertical plane wire 3630.

Although the cam 3230 is illustrated and described as defining a groove3232, in other embodiments, the cam is otherwise configured to engagethe first or second vertical plane wires 3610, 3630. For example, insome embodiments, the cam defines an opening configured to receive aportion of the first or second vertical plane wires 3610, 3630.

The second vertical plane wire 3630 is couplable to the steerable member3001 of the device 3000. For example, in the illustrated embodiment, thesecond end of the second vertical plane wire 3630 is couplable to thesteerable member 3001 of the device 3000.

The first vertical plane wire 3610 and the second vertical plane wire3630 are each movable in response to movement of the first actuator3400. For example, as illustrated in FIG. 6B, movement of the firstactuator 3400 in a first direction (indicated by arrow A₁) causesmovement of the steerable member 3001 in a first direction along thefirst plane.

When the first actuator 3400 is moved in the first direction from itsfirst position to its second position, the cam 3230 correspondinglymoves in a first direction from its first position to its secondposition. When the cam 3230 moves from its first position to its secondposition, the vertical plane wire 3610 engaged with or coupled to thecam 3230 correspondingly moves in a first direction from a firstposition to a second position different than the first position. Whenthe steering mechanism 3100 is coupled to the medical device 3000,movement of the first vertical plane wire 3610 from its first positionto its second position moves the steerable member 3001 of the device3000 in a first direction along a first plane, as illustrated in FIG.6B.

As illustrated in FIG. 6C, movement of the first actuator 3400 in asecond direction (indicated by arrow A₂) causes movement of thesteerable member 3001 in a second direction along the first plane.

When the first actuator 3400 is moved (or returned) to or towards itsfirst position from its second position, the cam 3230 moves in a seconddirection different that its first direction to or towards its firstposition. As the cam moves (or returns) to its first position, the cammoves (or pulls on) the second vertical plane wire 3630, which moves thesteerable member 3001 in its second direction along the first plane.

The first actuator 3400 is movable to a third position (illustrated inFIG. 6C) different than its first position and its second position. Thefirst actuator 3400 is movable in the second direction different thanthe first direction. For example, in some embodiments, the firstactuator 3400 is movable in a second direction that is opposite thefirst direction. The first actuator 3400 is moved in the seconddirection to its third position from its first or second position.

In FIGS. 6B and 6C, the steerable member 3001 is illustrated in anarticulated position, with the non-articulated (or relaxed) position ofthe steerable member illustrated in broken lines. For example, in someembodiments, the steerable member is a catheter or endoscope of greaterlength (such as compared to the length of the steering mechanism) thanthe steerable member in the illustrated embodiments.

Movement of the first actuator 3400 in the second direction to ortowards its third position moves the cam 3230 in its second directiondifferent than its first direction to a third position. Movement of thecam 3230 to its third position moves (or pulls on) the second verticalplane wire 3630 in a first direction. Movement of the second verticalplane wire 3630 in its first direction moves the steerable member of thedevice in its second direction along the first plane, as illustrated inFIG. 6C.

Thus, the steering mechanism 3100 controls articulation of the steerablemember of the device along the first plane. The first actuator 3400, inthe illustrated embodiment, is configured to control at leastbi-directional movement or articulation of the steerable member alongthe first plane.

As illustrated in FIGS. 3-7, the steering mechanism 3100 of the medicaldevice 3000 includes a second actuator 3500. The second actuator 3500 isconfigured to move the steerable member of the device along a secondplane different than the first plane (along which the first actuator3400 moves the steerable member). In some embodiments, the secondactuator 3500 is adapted to move the steerable member along a secondplane that is orthogonal to the first plane. For example, in someembodiments, the second actuator 3500 is adapted to move the steerablemember of the device along a substantially horizontal plane.

The second actuator 3500 is coupled to the housing 3200. In theillustrated embodiment, the second actuator 3500 is disposed on orcoupled to the proximal end portion 3210 of the housing 3200.Specifically, in the illustrated embodiment, the second actuator 3500 isdisposed on (or movably coupled to) the first actuator 3400, which isdisposed on or coupled to the proximal end portion 3210 of the housing3200.

The second actuator 3500 is movable between a first position(illustrated in FIG. 7A) and a second position (illustrated in FIG. 7B)different than the first position. The second actuator 3500 moves thesteerable member 3001 in a first direction along the second plane whenthe second actuator is moved in a first direction (indicated by arrowA₃) from its first position to its second position.

The second actuator 3500 is movable in a second direction (indicated byarrow A₄ in FIG. 7C) different than its first direction. As the secondactuator 3500 is moved (or returned) in its second direction from itssecond position to its first position, the steerable member 3001 movesin a second direction different than its first direction to or towardsits first position.

In FIGS. 7B and 7C, the steerable member 3001 is illustrated in anarticulated position, with the non-articulated (or relaxed) position ofthe steerable member illustrated in broken lines. For example, in someembodiments, the steerable member is a catheter or endoscope of greaterlength (such as compared to the length of the steering mechanism) thanthe steerable member in the illustrated embodiments.

In some embodiments, the second actuator 3500 is movable to a thirdposition (illustrated in FIG. 7C) different than its first position andits second position. The second actuator 3500 is moved to its thirdposition by moving the second actuator in the second direction differentthan the first direction, such as from its first or second position toits third position. In some embodiments, for example, the secondactuator 3500 is moved in a direction opposite the first direction tomove the actuator from at least one of its first or second positions toits third position.

As illustrated in FIG. 6, in some embodiments, the steering mechanism3100 includes a first horizontal plane wire 3620 and a second horizontalplane wire 3640. Each of the horizontal plane wires 3620, 3640 aremovable in response to movement of the second actuator 3500. The firstand second horizontal plane wires 3620, 3640 are configured to move thesteerable member 3001 of the device 3000 along the second planedifferent than the first plane, as illustrated in FIGS. 7A-7C.

The first horizontal plane wire 3620 is adapted to move the steerablemember in a first direction along the second plane. In some embodiments,the first horizontal plane wire 3620 is coupled to or otherwise engagesthe second actuator 3500 such that the first horizontal plane wire movesin response to movement of the second actuator.

For example, the first horizontal plane wire 3620 includes a first endand a second end (not shown). In some embodiments, the first end of thefirst horizontal plane wire 3620 is coupled to (or otherwise engages)the second actuator 3500. The second end of the first horizontal planewire 3620 is couplable to the steerable member 3001 of the medicaldevice 3000.

As the second actuator 3500 is moved in its first direction, the secondactuator moves the first horizontal plane wire 3620, which moves thesteerable member 3001 in its first direction, as illustrated in FIG. 7B.In some embodiments, for example, the first horizontal plane wire 3620is configured to move the steerable member 3001 in a first horizontaldirection, such as “right” from the perspective of the user.

The second horizontal plane wire 3640 is adapted to move the steerablemember 3001 in a second direction different than the first directionalong the second plane, as illustrated in FIG. 7C. In some embodiments,the second horizontal plane wire 3640 is configured to move thesteerable member in a second horizontal direction different than thefirst horizontal direction, such as “left” from the perspective of theuser.

The second horizontal plane wire 3640 defines or includes a first endand a second end (not shown). In some embodiments, the first end of thesecond horizontal plane wire 3640 is coupled to the second actuator3500. The second end of the second horizontal plane wire 3640 iscouplable to the steerable member.

As the second actuator 3500 moves in its second direction, such astowards its third position, the second actuator 3500 moves (or pulls on)the second horizontal plane wire 3640, which moves the steerable member3001 in its second direction, as illustrated in FIG. 7C.

Thus, the steering mechanism 3100 is adapted to control articulation ofthe steerable member 3001 along the second plane. Specifically, thesecond actuator 3500 is adapted to control at least bi-directionalmovement of the steerable member 3001 along the second plane. Forexample, in some embodiments, the steerable member is bi-directionallymovable along a horizontal plane, such that movement of the secondactuator 3500 in its first direction moves at least a portion of thesteerable member to the right from the perspective of the user andmovement of the second actuator in its second direction moves the atleast a portion of the steerable member to the left from the perspectiveof the user.

In some embodiments, the second actuator 3500 is adapted to directlytransfer motion to at least one of the first or second horizontal planewires 3620, 3640 coupled to a steerable member 3001 of the device. Forexample, in some embodiments, the second actuator 3500 engages or iscoupled to the horizontal plane wire 3620. As the second actuator 3500is moved from its first position to its second position, the motiongenerated from the movement of the second actuator transfers directly tothe horizontal plane wire 3620, for example, because there is nointermediary structure (like a cam) between the second actuator and thehorizontal plane wire.

Although the horizontal and vertical plane wires are described herein asmoving the steerable portion along a substantially horizontal orvertical plane, respectively, in other embodiments, the horizontaland/or vertical plane wires can move the steerable portion along adifferent plane.

As illustrated in FIGS. 3-6, in some embodiments, the second actuator3500 is a sliding actuator. The second actuator 3500 is moved betweenits first, second, and third positions by sliding the second actuator inthe first and/or second directions (indicated by arrows A₃ and A₄ inFIGS. 7B & 7C), for example left and right from the perspective of theuser. The sliding movement of the second actuator 3500 between itsdifferent positions directly transmits the motion onto the horizontalplane wires 3620, 3640 and without any substantial leverage.

In other embodiments, the steering mechanism 4100 includes a secondactuator 4500 that is a pivoting actuator, as illustrated in FIG. 9. Thesecond actuator 4500 pivots with respect to an axis P. The axis P isparallel to the longitudinal axis L (not illustrated) defined by thehousing 4200 of the steering mechanism 4100. As the second actuator 4500is moved from its first position to its second position in the directionof arrow A₅, the second actuator pivots with respect to the axis P. Thepivoting movement of the second actuator 4500 introduces motion withforce leverage directly onto the horizontal plane wires 4620, 4640. Auser can increase the force leverage, for example, by shifting his orher thumb or finger from the middle of the second actuator 4500 to afurther edge of the second actuator. The second actuator 4500 is moved(or returned) to its first position from its second position by movingthe second actuator in the direction of arrow A₆.

Although the second actuator 4500 is illustrated and described as beingmovable with respect to an axis P that is parallel to the longitudinalaxis L defined by the housing 4200, in other embodiments, the axis P isa different axis. For example, i n some embodiments, the axis P iscoaxial with the longitudinal axis L defined by the housing. In stillother embodiments, the axis P is different than, or non-coaxial with,the longitudinal axis L.

The second actuator 3500, 4500 is adapted for at least one-handedoperation by a user. In the illustrated embodiment, the second actuatordefines a curve or U-shape. The curve or U-shape allows the user to resta thumb or finger inside the curve or U-shape when manipulating oractuating the second actuator, as illustrated in FIGS. 7A-7C and 8A-8B.For example, during an endoscopic procedure, a physician can hold orrest the housing 4200 of the steering mechanism 4100 in his or her handand can substantially simultaneously move the second actuator 4500 withthe thumb of the same hand. Although the second actuator 4500 isillustrated as a curve or U-shape, the second actuator can be any knownshape, for example a circle or a rod.

Furthermore, referring to the embodiment illustrated in FIGS. 3-6, thefirst actuator 3400 and the second actuator 3500 of the steeringmechanism 3100 are adapted for one-fingered operation by a user. Forexample, during an endoscopic procedure, a physician can move the firstactuator 3400 with his or her thumb and, sequentially or substantiallysimultaneously, move the second actuator 3500 with the same thumbwithout having to readjust the position of the thumb or hand. Forexample, one-fingered operation of the steering mechanism 3100 by a useris facilitated when the second actuator 3500 is movably coupled to thefirst actuator 3400 because the user can maintain the position of his orher hand or finger while moving one or both of the first and secondactuators 3400, 3500.

In some embodiments, at least one of the first actuator 3400 and thesecond actuator 3500 is independently movable of the other of the firstactuator and the second actuator. Said another way, the manipulation ofone actuator does not affect the position of the other actuator. Forexample, in one embodiment, the second actuator can be moved between itsfirst position and its second position, and the position of the firstactuator is unchanged by movement of the second actuator. In anotherexample, movement of the first actuator from its second position to itsthird position does not change the position of the second actuator.

In some embodiments, the horizontal plane wires, which direct movementof the steerable member along the second plane, are configured to enterinto at least one opening (not shown) spatially located at the pivotingaxis of the first actuator, thus permitting movement of one of thehorizontal or vertical plane wires without affecting or causing movementof the other of the horizontal or vertical plane wire.

Because the first actuator 3400 and the second actuator 3500 areconfigured to move the steerable member along the first and secondplanes, respectively, the steering mechanism 3100 is configured to movethe steerable member of the device in substantially any direction 360degrees around or about the longitudinal axis L. Said another way, thesteering mechanism 3100 is adapted to achieve 360 degree articulation ofthe steerable member.

Although the steering mechanism 3100 has been described above asincluding a first and a second vertical plane wire 3610, 3630 movable bya first actuator 3400, in other embodiments, the steering mechanismincludes a single vertical plane wire. For example, in one embodiment, asteering mechanism includes a vertical plane wire that includes a firstend and a second end. The vertical plane wire is couplable to asteerable member of a medical device. For example, in some embodiments,at least one of the first end and the second end of the vertical planewire is couplable to a first portion of the steerable member.

In some embodiments, each of the first end and the second end of thevertical plane wire is couplable to the steerable member of the device.For example, in some embodiments, the first end of the vertical planewire is coupled to a first portion of the steerable member, the verticalplane wire extends through a portion of the inner cavity of the housingand around a portion of the cam, and the second end of the verticalplane wire is coupled to a second portion of the steerable member. Theportion of the vertical plane wire extending around the cam engages thecam, such as via a groove similar to the groove 3232 described abovewith respect to FIG. 5.

A portion of the vertical plane wire between the first and second endsof the vertical plane wire is coupled to the first actuator. As thefirst actuator is moved in a first direction, the vertical plane wire ismoved in a first direction, and a steerable member of a medical deviceis moved in a first direction along a first plane. As the first actuatoris moved in a second direction different than the first direction, thevertical plane wire is moved in a second direction, and the steerablemember of the medical device is moved in a second direction differentthan its first direction along the first plane.

Although the steering mechanism 3100 has been described above andillustrated as including a first and a second horizontal plane wire3620, 3640 movable by a second actuator 3500, in other embodiments, thesteering mechanism includes a single horizontal plane wire. For example,in one embodiment, a steering mechanism includes a horizontal plane wirethat includes a first end and a second end. The horizontal plane wire iscouplable to a steerable member of a medical device. For example, insome embodiments, at least one of the first and the second end of thehorizontal plane wire is couplable to a first portion of the steerablemember.

In some embodiments, each of the first end and the second end of thehorizontal plane wire is couplable to the steerable member of thedevice. For example, in some embodiments, the first end of thehorizontal plane wire is coupled to a first portion of the steerablemember, the horizontal plane wire extends through a portion of an innercavity of a housing, and the second end of the horizontal plane wire iscoupled to a second portion of the steerable member.

At least a portion of the horizontal plane wire extending through theinner cavity of the housing is coupled to the second actuator 3500. Asthe second actuator is moved in a first direction, the horizontal planewire is moved in a first direction, and a steerable member of a medicaldevice is moved in a first direction along a second plane. As the secondactuator is moved in a second direction different than the firstdirection, the horizontal plane wire is moved in a second direction, andthe steerable member of the medical device is moved in a seconddirection different than its first direction along the second plane.

In some embodiments, as illustrated in FIGS. 3 and 5, the apparatus 3000includes first and second ports 3270, 3260. The first port 3270 isadapted to be connected to a working channel 3274, or lumen, thatextends through at least a portion of the elongated member 3001 of theapparatus 3000 to or towards the distal end 3320 of the elongated member3001, such as to or towards a treatment site in a body of a patient. Thefirst port 3270 is adapted to receive medical instrumentation. Forexample, in some embodiments, the first port 3270 is adapted to receiveat least one of a guidewire, laser fiber, stone basket, biopsy device,or other medical instrumentation. The first port 3270 allows a physicianto insert the medical instrumentation into the working channel 3274, andthen through the elongated member 3001 to the treatment site. In oneprocedure, for example, a portion of a guidewire is passed through thefirst port 3270, through the working channel 3274, and to the treatmentsite.

The second port 3260 is adapted to transport an irrigation fluid, suchas saline, or gas, such as an air jet, from a source external to theapparatus 3000 into the first port 3270. The second port 3260 isfluidically connected to the first port 3270, which can be fluidicallyconnected to the working channel 3274 extending at least partiallythrough the elongated member 3001. The irrigation fluid can be passedthrough the second port 3260 to wash the medical instrumentation passedthrough the first port 3270. In one procedure, for example, anirrigation fluid is passed through the second port 3260 to wash offdebris, such as from broken stones being removed from the treatment siteby a stone basket that has been passed through the first port 3270.

In the illustrated embodiment, the second port 3260 extends radiallyfrom the first port 3270. In some embodiments, the ports 3260, 3270 areconfigured with a Y-shaped junction, as illustrated in FIG. 5. One orboth of ports 3260, 3270 can be monolithically constructed with thehousing 3200. In other embodiments, one or both of ports 3260, 3270 canbe separately constructed and then disposed on or coupled to the housing3200. Although ports 3260, 3270 are illustrated as being coupled to thedistal end 3220 of the housing 3200, in other embodiments, the ports canbe coupled to a different portion of the apparatus 3000.

In some embodiments, the apparatus 3000 includes or is adapted toreceive an electrical component (not shown). For example, as illustratedin FIGS. 3 and 5, the apparatus 3000 includes a third port 3250. Thethird port 3250 is adapted for channeling or receiving at least aportion of the electrical component. For example, in some embodiments,the third port is adapted to receive at least a portion of a signaltransmission line. In one procedure, the signal transmission line canextend from a point exterior to the apparatus 3000, through the thirdport 3250, and through the elongated member 3001 to or towards thedistal end 3320 of the elongated member 3001. The signal transmissionline, for example, can be adapted to transmit an image received by anoptical element at the distal end of the transmission line to an imagingsystem exterior to the apparatus 3000. In another example, the thirdport is adapted to receive at least a portion of an electrical componentincluding a fiber optic light and associated electrical cable. In someembodiments, the third port 3250 is monolithically constructed with thehousing 3200. In other embodiments, the third port 3250 is separatelyconstructed and then coupled to the housing 3200. Although the thirdport 3250 is illustrated as being coupled to the distal end 3220 of thehousing 3200, in other embodiments, the third port 3250 can be coupledto a different portion of the apparatus 3000.

Although the apparatus 3000 is illustrated and described as includingfirst port 3270, second port 3260, and third port 3250, in otherembodiments, the apparatus can include any combination of the first,second, and third ports, only one of the first, second, or third ports,or none.

In a procedure utilizing a steering mechanism according to the presentinvention, the user can hold or rest the housing in one of the user'shands, or rest the housing on a preferred location. The user places athumb or finger onto the second actuator. To move the steerable memberor portion of the medical device in a vertical direction, the user pullsor otherwise moves the second actuator around the end of the housing. Tomove the steerable member or portion in a horizontal direction, the userslides, pulls, or otherwise moves the first actuator to the left or tothe right from the perspective of the user. The user can substantiallysimultaneously move both the first actuator and the second actuator tomove the steerable member or portion in a direction other than avertical or horizontal direction. For example, the user cansubstantially simultaneously move or flip the first actuator around theproximal end portion of the housing and move the second actuator to theright to move the steerable member or portion at a 45 degree angle. Theuser can also achieve articulation of the steerable member or portion atthe 45 degree (or other) angle by sequentially moving the first actuatorand the second actuator. The steering mechanism is configured such thatthe user can control articulation of the steerable member or portion insubstantially any angle or direction that is 360 degrees about thelongitudinal axis L.

While various embodiments of the invention have been described above, itshould be understood that they have been presented by way of exampleonly and are not limiting on the invention. The breadth and scope of theinvention should not be limited by any of the above-describedembodiments.

The invention claimed is:
 1. A medical device, comprising: a handleextending along a longitudinal axis; a steerable member coupled to thehandle; and a steering system including: a first actuator rotatableabout a first axis different than the longitudinal axis between a firstposition and a second position, wherein in the first position, thesteerable member extends in a first direction along a first plane and inthe second position the steerable member extends in a second directionalong the first plane; and a second actuator moveably coupled to thefirst actuator and moveable between a first position and a secondposition about an axis other than the first axis, wherein in the firstposition, the steerable member extends in a first direction along asecond plane and in the second position the steerable member extends ina second direction along the second plane.
 2. The medical device ofclaim 1, wherein the second actuator is independently moveable relativeto the first actuator.
 3. The medical device of claim 1, wherein thefirst axis is perpendicular to the longitudinal axis.
 4. The medicaldevice of claim 1, wherein the first plane is a plane normal to thelongitudinal axis of the handle and the second plane is a plane normalto the first plane.
 5. The medical device of claim 1, further includingat least two first plane wires.
 6. The medical device of claim 1,further including at least two second plane wires.
 7. The medical deviceof claim 1, wherein the first actuator is pivotably coupled to aproximal end of the handle.
 8. The medical device of claim 1, furtherincluding a cam coupled to the first actuator.
 9. A medical device,comprising: a handle extending along a longitudinal axis; a steerablemember coupled to the handle; and a steering system including: a firstactuator rotatable about a first axis different than the longitudinalaxis between a first position and a second position, wherein in thefirst position, the steerable member extends in a first direction alonga first plane and in the second position the steerable member extends ina second direction along the first plane, wherein the first plane isnormal to the longitudinal axis of the handle; and a second actuatorcoupled to the first actuator and slideably moveable between a firstposition and a second position, wherein in the first position, thesteerable member extends in a first direction along a second plane andin the second position the steerable member extends in a seconddirection along the second plane, wherein the second plane is normal tothe first plane.
 10. The medical device of claim 9, wherein the secondactuator is independently moveable relative to the first actuator. 11.The medical device of claim 9, wherein the first axis is perpendicularto the longitudinal axis.
 12. The medical device of claim 9, wherein thefirst actuator is pivotably coupled to a proximal end of the handle. 13.The medical device of claim 9, wherein the first actuator is coupled toat least one first plane wire.
 14. A medical device, comprising: ahandle extending along a longitudinal axis; a steerable member coupledto the handle; and a steering system including: a first actuatorrotatable about a first axis different than the longitudinal axisbetween a first position and a second position, wherein in the firstposition, the steerable member extends in a first direction along afirst plane and in the second position the steerable member extends in asecond direction along the first plane, wherein the first actuator ispivotably coupled to a proximal end of the handle; and a second actuatorcoupled to the first actuator and moveable between a first position anda second position, the second actuator having a first portion positionedwithin the first actuator and a second portion positioned exterior ofthe second actuator, wherein in the first position, the steerable memberextends in a first direction along a second plane and in the secondposition the steerable member extends in a second direction along thesecond plane.
 15. The medical device of claim 14, wherein the first axisis perpendicular to the longitudinal axis.
 16. The medical device ofclaim 14, further including a cam coupled to the first actuator.
 17. Themedical device of claim 14, wherein the first plane is a plane normal tothe longitudinal axis of the handle and the second plane is a planenormal to the first plane.
 18. The medical device of claim 14, furtherincluding at least two first plane wires.
 19. The medical device ofclaim 14, further including at least two second plane wires.
 20. Themedical device of claim 14, wherein the first actuator includes a firstend coupled to the handle, a second end opposite the first end, and anarm extending between the first end and the second end, wherein aportion of the handle is positioned within an opening defined by the armbetween the first end and the second end.